Effect of Erector Spinae Plane Block on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fudan University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Post-operative acute pain score at 6 hours
Study Overview
Brief Summary
Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery.With the development of medical technology and concept, radical mastectomy combined breast reconstruction are becoming more and more popular.But the reconstruction caused greater trauma and more severe postoperative pain.ESPB is a new nerve block method which thought to reduce pain after thoracic and breast surgery.However, there are few studies on radical mastectomy combined breast reconstruction. So, this randomized controlled study is conducted to explore its impact on postoperative pain and thus provide more data guidance for clinical.
Detailed Description
Patients: 100 breast cancer patients who are planned radical mastectomy combined breast reconstruction Intervention: General anesthesia + erector spinae plane block Control ： General anesthesia Outcome: NRS(Numerical rating scale) of postoperative pain at the sixth hour Study:RCT
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients scheduled for an radical mastectomy and implant reconstruction surgery
- •Patients with American Society of Anesthesiologists (ASA) physical status I-II,
- •aged 18-70 years
Exclusion Criteria
- •coagulation disorders,
- •known allergy to study drugs,
- •obesity (body mass index > 35 kg/m2),
- •infection at the injection site,
- •chronic opioid consumption, and an inability to use patient-controlled analgesia (PCA) device,
- •patient refuse
Arms & Interventions
Control group
Control groups do not receive additional analgesia.
Erector spinae plane block group
Before surgery, an ultrasound-guided ESPB was performed. 30 mL of 0.375% ropivacaine and 0.5μ g/kg dexmedetomidine mixture was injected in the interfascial plane between rhomboideus major and erector spinae muscle.
Ropivacaine is produced by AstraZeneca AB under the trade name of Naropin, and the specifications are 75 mg / 10 ml. Dexmedetomidine is produced by HengRui medical China and the specifications are 100μg / 1 ml。
Intervention: Erector spinae plane block (Procedure)
Outcomes
Primary Outcomes
Post-operative acute pain score at 6 hours
Time Frame: 6 hours After surgery
11-point numerical rating scale(0=no pain, 10=worst pain) at 6th hour following the surgery
Secondary Outcomes
- Postoperative quality of recovery score(24 to 72 hours after the surgery)
- AUC of postoperative pain score(72 hours after the surgery)
- Post-operative acute pain score(1h, 12h,24, 48h, 72h after the surgery, separately.)
- Cumulative opioid consumption after surgery(48 hours after the surgery)
Investigators
Jun Zhang
Director of the department of anaesthesiology, Shanghai cancer center
Fudan University